StrokeBiAsNCT02778529
Arm Motor Control on Bi and Uni ADLs
A study testing Bilateral assessment robots (BiAS) in people with Stroke and Peripheral Neuropathy, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Peripheral Neuropathy, Spinal Cord Injuries
- What is being tested?
- Bilateral assessment robots (BiAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study will include subjects 18 years of age or older from any of the below groups:
- Stroke survivors, 3 months post event
- Upper extremity amputees, 3 months post event
- Cervical SCI (C-5 to C-7), 3 months post event
- Cerebral palsy participants
- Healthy participants
Who cannot join
- The inability to perform at least some aspects of ADL tasks such as drinking, pouring, pinching, and grasping.
- Severe spasticity
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
Official title: Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study
This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. By studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (ADLS), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect ADLs in patients with differing long-term disabilities.
Read the detailed description
Cross-sectional study comparing bilateral ADL activities for stroke survivors, SCI paraplegics, UE amputees, adults with CP, and healthy controls. The study participants will perform 4 ADL tasks with the BiAS passive robots. From these tasks, the BiAS robots will provide information regarding position, velocity, distance, displacement, etc. This, along with video information provided by the 3D Kinect and EEG neuroheadset, will be used as the basis of the investigators data and aid in informing members of the research team on how the respective impairments affected upper limb kinematics on ADL tasks.
Participation in the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
- Pre-Assessments: A member of the research team will evaluate the subjects' upper extremity and assess their ability to use it. Subjects will be evaluated using a battery of assessments such as, but not limited to, the Box and Block, Pin and Prick, and grip strength using a dynamometer.
- Break: Subjects will be given a 15 minute break.
- BiAS passive robot system: Subjects will be introduced to the device and each wrist will be placed on to the end of each robot. As common therapy tasks are performed by the subject, the BiAS devices will collect the data along with the video from 3D Kinect, ECG gelled electrodes, and the EEG neuroheadset. After each of the 4 ADL activities, subjects will be asked about their level of exercise and discomfort, if any. After subjects finish all exercises with the BiAS, they will be thanked for their participation in the study.
- Video and photos may be collected to determine subject quality of ADL movement.
- Conditions
- Stroke, Peripheral Neuropathy, Spinal Cord Injuries, Cerebral Palsy
- Being tested
- Bilateral assessment robots (BiAS)
- Keywords
- stroke, amputees, spinal cord injuries, cerebral palsy, robotics, rehabilitation
- Medical subject headings
- Stroke, Peripheral Nervous System Diseases, Spinal Cord Injuries, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral assessment robots (BiAS)Device
The BiAS are two passive desktop robots that will be used in this study to measure right and left arm kinematics for 4 different groups of patients.
| Study group | Role | What they receive |
|---|---|---|
| Upper Limb Assessment on ADLs | Other | Bilateral assessment robots (BiAS) Evaluate upper limb kinematics of Stroke, Amputees, SCI, Cerebral Palsy and Health Subjects will be assessed as they complete unilateral and bilateral activities of daily living. Subjects will complete exercises in 1 session Receives: Device: Bilateral assessment robots (BiAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interlimb Coordination: Movement Overlap (MO)
Kinematic Variables of Movement Overlap. Movement Overlap (MO): MO is defined as the time when both hands were in motion as a percentage of total Task Completion Time.
Measured: approximately 3 hours
Movement Time
Time to completion (TCT) was defined for unimanual tasks and bimanual tasks - left arm and right arm; Two tasks were completed Drink and Pour. Shorter times means better performance.
Measured: approximately 3 hours
Interlimb Coordination: Phase Difference (PD)
Kinematic Variables of Phase Difference (PD). PD describes the lag between the two limbs as a measure of the synchronization of the two arms: dominant (less-impaired) phase less non-dominant (impaired) phase. Phase was calculated from the arctangent of the ratio of velocity to displacement.
Measured: approximately 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2023
- Study completionSep 2023
Why it stopped: Equipment Failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle J Johnson, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778529
- Sponsor's protocol ID
- 820251
- Acronym
- BiAs
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2016
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dimwamwa E, Johnson MJ. Kinematic analysis of unilateral and bilateral drinking task after brain and periphery injuries. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:4558-61. doi: 10.1109/EMBC.2015.7319408.
PubMed 26737308Johnson MJ, Wang S, Bai P, Strachota E, Tchekanov G, Melbye J, McGuire J. Bilateral assessment of functional tasks for robot-assisted therapy applications. Med Biol Eng Comput. 2011 Oct;49(10):1157-71. doi: 10.1007/s11517-011-0817-0. Epub 2011 Sep 1.
PubMed 21881901
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study
- ClinicalTrials.gov ID
- NCT02778529
- Acronym / sponsor ID
- BiAs / 820251
- Conditions
- Stroke, Peripheral Neuropathy, Spinal Cord Injuries, Cerebral Palsy
- Keywords
- stroke, amputees, spinal cord injuries, cerebral palsy, robotics, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Equipment Failure
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Posted 10 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. By studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (ADLS), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect ADLs in patients with differing long-term disabilities.
Detailed description
Cross-sectional study comparing bilateral ADL activities for stroke survivors, SCI paraplegics, UE amputees, adults with CP, and healthy controls. The study participants will perform 4 ADL tasks with the BiAS passive robots. From these tasks, the BiAS robots will provide information regarding position, velocity, distance, displacement, etc. This, along with video information provided by the 3D Kinect and EEG neuroheadset, will be used as the basis of the investigators data and aid in informing members of the research team on how the respective impairments affected upper limb kinematics on ADL tasks.
Participation in the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
- Pre-Assessments: A member of the research team will evaluate the subjects' upper extremity and assess their ability to use it. Subjects will be evaluated using a battery of assessments such as, but not limited to, the Box and Block, Pin and Prick, and grip strength using a dynamometer.
- Break: Subjects will be given a 15 minute break.
- BiAS passive robot system: Subjects will be introduced to the device and each wrist will be placed on to the end of each robot. As common therapy tasks are performed by the subject, the BiAS devices will collect the data along with the video from 3D Kinect, ECG gelled electrodes, and the EEG neuroheadset. After each of the 4 ADL activities, subjects will be asked about their level of exercise and discomfort, if any. After subjects finish all exercises with the BiAS, they will be thanked for their participation in the study.
- Video and photos may be collected to determine subject quality of ADL movement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper Limb Assessment on ADLs | Other | Device: Bilateral assessment robots (BiAS)Bilateral assessment robots (BiAS) Evaluate upper limb kinematics of Stroke, Amputees, SCI, Cerebral Palsy and Health Subjects will be assessed as they complete unilateral and bilateral activities of daily living. Subjects will complete exercises in 1 session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke survivors, 3 months post event
- Upper extremity amputees, 3 months post event
- Cervical SCI (C-5 to C-7), 3 months post event
- Cerebral palsy participants
- Healthy participants
Key exclusion criteria (2 listed)
- The inability to perform at least some aspects of ADL tasks such as drinking, pouring, pinching, and grasping.
- Severe spasticity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral assessment robots (BiAS)The BiAS are two passive desktop robots that will be used in this study to measure right and left arm kinematics for 4 different groups of patients. | Device | Upper Limb Assessment on ADLs |
Primary outcome
Interlimb Coordination: Movement Overlap (MO)
Time frame: approximately 3 hours
Kinematic Variables of Movement Overlap. Movement Overlap (MO): MO is defined as the time when both hands were in motion as a percentage of total Task Completion Time.
Movement Time
Time frame: approximately 3 hours
Time to completion (TCT) was defined for unimanual tasks and bimanual tasks - left arm and right arm; Two tasks were completed Drink and Pour. Shorter times means better performance.
Interlimb Coordination: Phase Difference (PD)
Time frame: approximately 3 hours
Kinematic Variables of Phase Difference (PD). PD describes the lag between the two limbs as a measure of the synchronization of the two arms: dominant (less-impaired) phase less non-dominant (impaired) phase. Phase was calculated from the arctangent of the ratio of velocity to displacement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26737308Dimwamwa E, Johnson MJ. Kinematic analysis of unilateral and bilateral drinking task after brain and periphery injuries. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:4558-61. doi: 10.1109/EMBC.2015.7319408.
- Background: PubMed 21881901Johnson MJ, Wang S, Bai P, Strachota E, Tchekanov G, Melbye J, McGuire J. Bilateral assessment of functional tasks for robot-assisted therapy applications. Med Biol Eng Comput. 2011 Oct;49(10):1157-71. doi: 10.1007/s11517-011-0817-0. Epub 2011 Sep 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle J Johnson, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral assessment robots (BiAS) in people with Stroke and Peripheral Neuropathy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interlimb Coordination: Movement Overlap (MO) (time frame: approximately 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778529, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.